Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
168 participants
INTERVENTIONAL
2023-12-01
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients will be randomly assigned to either the intervention or control group. Patients assigned to the intervention group will participate in a 6-month exercise training program followed by a 6-months non-supervised and home-based physical activity maintenance program. During the first 6 months, patients in the intervention group participate in 18 supervised exercise sessions at the DSBG, interspersed by unsupervised exercise interventions at home.
All patients will be seen at baseline, after three months and six months of aerobic exercise training, and after another six months of physical activity and exercise self-maintenance (intervention group) or control condition. Each subject will be asked to undergo standard ophthalmic examination, non-invasive retinal assessments, peripheral blood withdrawal, and additional peripheral vascular examinations. The study design is based on regular glaucoma follow-up intervals (every 6 months) and does not intervene with clinical care and governmental reimbursement of standard care. Patients will finish their study participation after 6 months of exercise training followed by 6 months of physical activity and exercise self-maintenance or control condition.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
Group performing exercise training and receiving standard care
Exercise Training
6-months supervised exercise training + 6 months unsupervised exercise training
Control Group
Group receiving lifestyle counseling and receiving standard care
Lifestyle Counselling
12-months of lifestyle counselling
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise Training
6-months supervised exercise training + 6 months unsupervised exercise training
Lifestyle Counselling
12-months of lifestyle counselling
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with primary open angle glaucoma (POAG), high tension glaucoma (HTG) and normal tension glaucoma (NTG), aged 40 - 75 years
* In regular follow-up in either of the two study centres
Exclusion Criteria
* Patients with changes in topical medication or laser trabeculoplasty within 3 months before start of the project
* Patients with very severe glaucoma (visual field mean deviation lower than -12Db)
* Significant opacification of ocular media
* Patients with life-threatening arrhythmia, signs of ischemia during CPET which preclude participation in an exercise trial
* Patients with insulin treated diabetes, chronic obstructive pulmonary disease or cancer.
* Patients doing ≥1 structured exercise training session per week or \>150min of exercise/week assessed via the following two questions: a. On average, how many days per week do you engage in moderate to vigorous physical activity (like brisk walking)? b. On average, how many minutes per day do you engage in physical activity at this level? Calculate the total weekly minutes of exercise by multiplying a times b.
* Mental or physical limitation precluding participation in a high intensity exercise program
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitaire Ziekenhuizen KU Leuven
OTHER
University Hospital, Basel, Switzerland
OTHER
Henner Hanssen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henner Hanssen
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Basel, Department of Sport, Exercise & Health
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Van Eijgen J, Schuhmann V, Fingerroos EL, Renier M, Burchert H, Kropfl JM, Van Craenenbroeck A, Cornelissen V, Gugleta K, Stalmans I, Hanssen H. High-intensity interval training in patients with glaucoma (HIT-GLAUCOMA): protocol for a multicenter randomized controlled exercise trial. Front Physiol. 2024 May 16;15:1349313. doi: 10.3389/fphys.2024.1349313. eCollection 2024.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-01397
Identifier Type: -
Identifier Source: org_study_id